Fwd: ADHD Drugs Induce Hallucinations in Kids--FDA safety Officers

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThree years have elapsed since FDA medical officers reported the findings oftheir comprehensive review of clinical trial data at an FDA pediatricadvisory committee hearing (March, 2006). The review included 49 randomized,controlled clinical trials in the pediatric development programs, as well aspostmarketing adverse event reports (AERS). The evidence shows thathallucinations and other psychotic symptoms emerge in children prescribedevery one of the ADHD drugs: In controlled trials, only children taking thedrugs suffered treatment-emergent "Hallucinations involving visual and/ortactile sensations of insects, snakes, or worms..." whereas none of thechildren on placebo hallucinated or became psychotic.Further underscoring that the drugs are to blame: Dr. Andrew Mosholder andcolleagues report, that in 90% of the cases, "there was no reported historyof a similar psychiatric condition."  The authors note: "Patients andphysicians should be aware that psychosis or mania arising during drugtreatment of attention-deficit/hyperactivity disorder may represent adversedrug reactions."The findings have finally been published by the Amer Academy of Pediatricsin its journal, Pediatrics (Abstract below). It is exceedingly troubling that publication of such vital drug safetyinformation was held up for three years--especially since this analysis hadbeen vetted at the FDA.One can only suspect that the delay was due to major conflicts ofinterest--the worrisome scientific findings collide with the financialinterests of the American Academy of Pediatrics.http://www.aap.org/donate/fcfhonorroll.htmAAP- ADHD diagnostic criteria (2000) expand the roster of children who willbe "diagnosed" with ADHD--indeed, they recommend AGAINST screening forpossible biological malfunctions: "the AAP recommends that other diagnostictests be discarded in determining an ADHD diagnosis. Screening for high leadlevels, for example, or abnormal thyroid hormone levels should not beconsidered a routine corollary in the ADHD diagnosis."http://aappolicy.aappublications.org/cgi/reprint/pediatrics;105/5/1158.pdfAAP Treatment recommendations promote the use of drugs:http://www.aap.org/pubserv/adhdtoolkit/index.htmThe ADHD Management Plan - Sample 1 outlines behavior improvement goals anda medication schedule with details regarding timing and possible sideeffects.The ADHD Management Plan - Sample 2 outlines behavior improvement goals anda simple medication schedule.Contact: Vera Hassner Sharavveracare212-595-8974http://pediatrics.aappublications.org/cgi/content/abstract/123/2/611Hallucinations and Other Psychotic Symptoms Associated With the Use ofAttention-Deficit/Hyperactivity Disorder Drugs in Children.Andrew D. Mosholder, MD, MPHa, Kate Gelperin, MD, MPHa, Tarek A. Hammad, MD,PhD, MSc, MSa, Kathleen Phelan, RPha,Rosemary Johann-Liang, MDb.  PEDIATRICS, Vol. 123 No. 2 February 2009, pp.611-616 aOffice of Surveillance and Epidemiology, Center for Drug Evaluation andResearch, US Food and Drug Administration, Silver Spring, Maryland; bHealthResources andServices Administration, Department of Health and Human Services, Rockville,MarylandABSTRACTOBJECTIVES. To gain a better understanding of the capacity ofpsychostimulant medications to induce adverse psychiatric reactions anddetermine the frequency of suchreactions, we analyzed postmarketing surveillance data and clinical trialdata for drugs, either approved or under development, for the treatment ofattention-deficit/hyperactivity disorder.METHODS. The US Food and Drug Administration requested manufacturers ofdrugs approved for attention-deficit/hyperactivity disorder or with activeclinical developmentprograms for that indication to search their electronic clinical trialdatabases for cases of psychosis or mania using prespecified search terms.The manufacturerssupplied descriptions of clinical trials, numbers of patients exposed tostudy drug, and duration of exposure to permit calculations of incidencerates. Independently, casesof psychosis or mania in children and adults for drugs used to treatattention-deficit/hyperactivity disorder from the Food and DrugAdministration Adverse Event ReportingSystem safety database were analyzed. Manufacturers were asked to conductsimilar analyses of their postmarketing surveillance databases.RESULTS.We analyzed data from 49 randomized, controlled clinical trials inthe pediatric development programs for these products. A total of 11psychosis/mania adverse events occurred during 743 person-years ofdouble-blind treatment with these drugs, and no comparable adverse eventsoccurred in a total of 420 person-years ofplacebo exposure in the same trials. The rate per 100 person-years in thepooled active drug group was 1.48. The analysis of spontaneous postmarketingreports yielded 800 reports of adverse events related to psychosis ormania. In 90% of the cases, there was no reported history of a similarpsychiatric condition. Hallucinations involving visual and/or tactilesensations of insects, snakes, or worms were common in cases in children.CONCLUSIONS. Patients and physicians should be aware that psychosis or maniaarising during drug treatment of attention-deficit/hyperactivity disordermay represent adverse drug reactions. Pediatrics 2009;123:611-616FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.